Two Different Dates Called "Expiry"
"My MDD certificate expires" can mean two different things, and the regulation treats them differently. The first is the date printed on the certificate itself, set by the notified body when it was issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD). The second is the transitional date set by MDR Article 120 for devices that qualify for an extension past that printed date. A certificate can reach its printed date and still be valid, or it can reach its printed date and simply end, depending on which rule applies to it.
MDR Article 120 splits legacy certificates into two groups by issue date. Certificates issued by a notified body before May 25, 2017 remain valid until the date printed on them, with one exception: certificates issued under Annex 4 of the AIMDD or Annex IV of the MDD become void at the latest on May 27, 2022, regardless of what date is printed on them. Certificates issued from May 25, 2017 onward, that were still valid on May 26, 2021 and have not been withdrawn since, are the group this guide is about: their printed expiry date is not the date that matters.
The Automatic Extension, and Its Condition
For that second group, Article 120(2) of the MDR extends the certificate past its printed date, "until the date set out in paragraph 3a", which is December 31, 2027 for Class III devices and Class IIb implantables other than a listed set (sutures, staples, screws, plates, wires, clips and similar items), or December 31, 2028 for other Class IIb, Class IIa, and sterile or measuring Class I devices. Apart from those eligibility requirements and the look-back rule for certificates that expired before March 20, 2023 (covered below), paragraph 2 sets no further condition on the certificate itself, but the right to keep placing the device on the market is conditional. Paragraph 3 says devices covered by paragraphs 3a and 3b "may be placed on the market or put into service until the dates set out in those paragraphs" only "provided the conditions set out in paragraph 3c of this Article are met". The extension and its condition are written in different paragraphs, so a certificate can be valid under paragraph 2 while the device still may not be placed on the market under it, for example because the 2024 deadlines in paragraph 3c were missed.
The Conditions With 2024 Deadlines
Article 120(3c) lists five conditions, points (a) to (e). Three are ongoing: the device must keep complying with the Directive it was certified under, there must be no significant change in its design or intended purpose, and it must not present an unacceptable risk. The other two, points (d) and (e), are dated. Together they set three deadlines, all in 2024.
| Condition | Deadline |
|---|---|
| Manufacturer has a quality management system in place under Article 10(9) of the MDR | No later than May 26, 2024 |
| Manufacturer or authorised representative has lodged a formal application with a notified body for conformity assessment of the device, or of a device intended to substitute it | No later than May 26, 2024 |
| The notified body and the manufacturer have signed a written agreement for that conformity assessment | No later than September 26, 2024 |
The right to keep placing the device on the market depends on these deadlines. A manufacturer who never lodged that application, or whose notified body never signed the written agreement, did not fail a renewal. The device could not be placed on the market under the paragraph 3a or 3b dates at all.
Certificates That Expired Before March 2023
There is a narrower, separate rule for certificates that had already expired before March 20, 2023. Article 120(2) states that certificates from the May 2017 to May 2021 group "that have expired before 20 March 2023 shall be considered to be valid" through the paragraph 3a dates only if one of two conditions is met: either the manufacturer and a notified body signed a written agreement for conformity assessment before the certificate's own date of expiry, or a competent authority granted a derogation under Article 59(1) or required the conformity assessment under Article 97(1). Here the written agreement had to predate the certificate's own expiry, not just the later fixed deadline in Article 120(3c). A certificate that lapsed in, say, 2022, with no agreement signed before it lapsed and no competent authority action, does not count as valid, and the 2024 deadlines do not revive it. A certificate that does pass this test is still subject to the Article 120(3c) conditions before the device may be placed on the market. The two tests add up; one does not replace the other.
No New MDD Certificate After a Significant Change
MDCG 2020-3 Rev.1, the Medical Device Coordination Group's guidance on significant changes under this transition, is explicit: "[I]t is important to highlight that no issuing of new AIMDD/MDD certificates is allowed under Article 120(3c), point (b)" of the MDR. A notified body can confirm in writing that a proposed change is not significant and that the existing certificate remains valid, and the guidance says the certificate should not be amended. The guidance adds, in its own footnote, what happens if a change is judged significant: "[S]hould the manufacturer wish to place such a changed device on the market, they may do so under the MDR".
What Still Continues After the Window Closes
Losing the right to place the device on the market does not take away the right to keep making available devices already placed on it. Article 120(4) of the MDR draws that line directly: devices lawfully placed on the market under the Directives before May 26, 2021, and devices lawfully placed on the market from that date under paragraphs 3, 3a, 3b or 3f, "may continue to be made available on the market or put into service". That wording differs from paragraph 3, which covers devices being "placed on the market or put into service". Paragraph 4 protects the stock that was already, lawfully, placed on the market while the certificate or its extension was valid. It does not reopen a window for placing devices on the market afterward. After the paragraph 3a or 3b date, or once a paragraph 3c condition is no longer met, paragraph 3 no longer allows placing the device on the market under the Directive certificate.
MDR Article 120(3d) adds one more point that is easy to miss during this whole window: post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices apply to legacy devices under the MDR itself, in place of the Directive's equivalents. The Directive certificate does not displace those MDR requirements.
This Is Not the November 2026 Deadline
Everything above is about whether a device may still be placed on the market under its old certificate. The November 27, 2026 deadline, set by MDR Article 123(3) as triggered by Commission Decision (EU) 2025/2371, is a separate obligation: completing the device's EUDAMED registration data. A device can be fully compliant on one and still fail the other. A legacy device whose certificate extension correctly runs to December 31, 2027 can still be unregistered in EUDAMED past November 27, 2026, and a device fully registered in EUDAMED can still lose its right to be placed on the market if the Article 120(3c) conditions are not met. Our legacy device registration guide covers the EUDAMED-DI and EUDAMED ID mechanism these devices use for the registration side; our November 2026 deadline guide covers the registration deadline itself, and what missing it actually triggers.
What to Check Before You Assume You're Covered
A device's current status under Article 120 is not something to infer from the date printed on the certificate. It depends on a sequence of facts specific to that device and that notified body relationship.
| Question | Why It Matters |
|---|---|
| Was the certificate valid on May 26, 2021, and has it been withdrawn since? | Only a certificate valid on that date and never withdrawn is eligible for the Article 120(2) extension at all |
| Did the certificate expire before March 20, 2023? | If so, the look-back condition applies first: a written agreement signed before the original expiry date, or a competent authority action under Article 59(1) or 97(1). The 2024 conditions still apply on top |
| Was a quality management system in place, and a formal notified body application lodged, by May 26, 2024? | Missing either date means the device may not be placed on the market under the paragraph 3a or 3b dates, whatever the certificate shows |
| Was the written agreement with the notified body signed by September 26, 2024? | The same condition, with its own later deadline; both dates had to be met, not just one |
| Has there been a significant change in the device's design or intended purpose since May 26, 2021? | Article 120(3c), point (b) excludes devices with significant changes in design or intended purpose, and MDCG 2020-3 Rev.1 states that no new AIMDD or MDD certificate may be issued for a significantly changed device |
Common Mistakes
| Mistake | What Actually Applies |
|---|---|
| Reading the certificate's printed date as the device's real deadline | For the May 2017 to May 2021 group, the placing-on-the-market date is set by Article 120(3a), conditional on Article 120(3c), not the printed date |
| Assuming the 2024 conditions were a one-time box to tick | Article 120(3c) also requires ongoing compliance, no significant change, and no unacceptable risk, for the whole extension period |
| Expecting a notified body to issue a renewed MDD or AIMDD certificate for a device that has had a significant design or intended-purpose change | MDCG 2020-3 Rev.1 states this is not allowed under Article 120(3c), point (b); the forward path is MDR conformity assessment |
| Treating "devices already placed on the market can still be made available" as "the device can still be placed on the market" | Article 120(4) protects making already-placed devices available; it does not extend the paragraph 3 right to place devices on the market |
| Conflating the certificate's market-placement date with the EUDAMED registration deadline | These come from different articles, Article 120 and Article 123(3), and are tracked separately |
Primary Sources
This guide cites the regulation text and the Medical Device Coordination Group's guidance on this transition.
| Document | Covers |
|---|---|
| Regulation (EU) 2017/745 (MDR), Article 120, consolidated text as amended by Regulation (EU) 2023/607 | The two certificate groups by issue date, the paragraph 2 extension and its pre-March-2023 look-back condition, the paragraph 3a and 3b dates, the paragraph 3c conditions and their 2024 deadlines, and the paragraph 4 making-available rule |
| MDCG 2020-3 Rev.1, "Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD" (May 2023) | Confirms that no new AIMDD or MDD certificate may be issued under Article 120(3c), point (b), and that a manufacturer who wishes to place a significantly changed device on the market may do so under the MDR |
The Directive route for a given device closes once its Article 120 conditions stop being met. For a significantly changed device, MDCG 2020-3 Rev.1 states that no new AIMDD or MDD certificates may be issued under Article 120(3c), point (b). Devices already placed on the market can still be made available under Article 120(4). Placing the device on the market after that point requires meeting the MDR, which for a device that needs a notified body under the MDR means conformity assessment with an MDR notified body.
Frequently Asked Questions
What happens when an MDD certificate reaches the date printed on it?
It depends on when the certificate was issued and whether it was still valid on May 26, 2021. A certificate issued before May 25, 2017 simply remains valid until the date printed on it, except that certificates issued under Annex 4 of the AIMDD or Annex IV of the MDD became void on May 27, 2022 at the latest. A certificate issued from May 25, 2017 that was valid on May 26, 2021 and never withdrawn is different: Article 120(2) of the MDR keeps it valid past its printed date (if it already expired before March 20, 2023, only where a written agreement with a notified body was signed before it expired or a competent authority acted under Article 59(1) or 97(1)), but Article 120(3) lets the device be placed on the market under it only if the separate conditions in Article 120(3c) are met, including deadlines that fell in 2024.
Were the Article 120(3c) conditions a one-time deadline, or do they apply continuously?
Both. The manufacturer needed a quality management system in place and a formal notified body application lodged by May 26, 2024, with a signed written agreement by September 26, 2024. Those deadlines are fixed and have passed. But Article 120(3c) also requires the device to keep complying with the original Directive, to have no significant change in design or intended purpose, and to present no unacceptable risk, for as long as the manufacturer keeps placing the device on the market under Article 120(3a) or (3b). Meeting the 2024 deadlines once is not enough on its own.
If my MDD certificate already expired and I missed the 2024 deadlines, is there any way back in?
Not under the Directive. Article 120(3c), points (d) and (e) make the May 26, 2024 and September 26, 2024 deadlines a condition for placing the device on the market under the Article 120(3a) or (3b) dates, and those deadlines cannot be met after the fact. For a device that has been significantly changed, MDCG 2020-3 Rev.1 states that no issuing of new AIMDD or MDD certificates is allowed under Article 120(3c), point (b) of the MDR. Its footnote adds that a manufacturer who wishes to place a significantly changed device on the market may do so under the MDR. Once a device can no longer be placed on the market under Article 120, the way forward is conformity assessment under the MDR.
Can I keep selling units I already shipped, even if I can't place new ones on the market?
Yes, that is a different act under the regulation. Article 120(4) of the MDR says devices lawfully placed on the market under the Directives before May 26, 2021, and devices lawfully placed on the market from that date under paragraphs 3, 3a, 3b and 3f, may continue to be made available on the market or put into service. Paragraph 4 speaks of making available. The right to place devices on the market comes from paragraph 3, and it ends at the paragraph 3a or 3b date or when a paragraph 3c condition is no longer met.
Is the MDD certificate expiry date the same thing as the November 27, 2026 EUDAMED deadline?
No. Article 120 governs how long a device may keep being placed on the market under its old Directive certificate: December 31, 2027 or December 31, 2028 depending on device class, if the conditions above are met. The November 27, 2026 date comes from a different provision, MDR Article 123(3), and is about completing EUDAMED registration, not about certificate validity. A device can be fully inside its Article 120 market-placement window and still be late on EUDAMED registration, or vice versa.